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Initial Drainage Method and Flexible Ureteroscopy Outcomes in Calculous Anuria

30 maja 2026 zaktualizowane przez: Hany Fathy Badawy, MD, Beni-Suef University

Impact of Initial Drainage Method on Flexible Ureteroscopy Outcomes in Patients Presenting With Calculous Anuria: A Multicenter Prospective Randomized Controlled Trial

Calculous anuria caused by obstructing upper ureteral stones in a solitary functioning kidney is a urological emergency requiring urgent decompression. Both retrograde JJ ureteral stenting and percutaneous nephrostomy are commonly used emergency drainage methods. However, limited evidence is available regarding whether the initial drainage method affects subsequent definitive flexible ureteroscopy/retrograde intrarenal surgery outcomes.

This multicenter prospective randomized controlled trial will compare emergency JJ ureteral stent drainage versus percutaneous nephrostomy drainage in adult patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, all participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery. The study will assess renal functional recovery, first-session surgical success, stone-free rate, operative parameters, complications, and microbiological outcomes.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is a multicenter prospective randomized controlled trial comparing two emergency drainage strategies before definitive flexible ureteroscopy/retrograde intrarenal surgery in patients presenting with calculous anuria.

Adult patients with calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney will be assessed for eligibility. Eligible participants will be randomized in a 1:1 ratio to emergency retrograde JJ ureteral stent drainage or emergency percutaneous nephrostomy drainage. Randomization will be performed using a computer-generated random sequence, with allocation concealment using sequentially numbered opaque sealed envelopes.

Participants assigned to the JJ stent group will undergo emergency retrograde placement of a 6 Fr JJ ureteral stent under cystoscopic guidance. Participants assigned to the percutaneous nephrostomy group will undergo emergency ultrasound-guided placement of an 8 Fr nephrostomy tube. After drainage, participants will be monitored for urine output recovery, renal functional improvement, symptom relief, and clinical stabilization.

Definitive flexible ureteroscopy/retrograde intrarenal surgery will be scheduled after renal functional improvement, clinical stabilization, and negative or appropriately treated urine culture. The definitive procedure will be performed using a standardized operative strategy. Ureteral access sheath use, successful insertion, need for adjunctive ureteral maneuvers, operative time, laser time, fluoroscopy time, postoperative stenting, complications, and hospital stay will be recorded.

The primary outcome is renal functional recovery after initial drainage and definitive surgery, assessed using serial serum creatinine measurements at presentation, 24 to 48 hours after drainage, before definitive surgery, postoperative day 1, and follow-up. Secondary outcomes include first-session definitive surgery success, stone-free rate, technical operative variables, intraoperative and postoperative complications, microbiological culture patterns, and predictors of surgical success or postoperative complications.

Participants will be followed for approximately one month after definitive surgery by clinical assessment, laboratory evaluation, and imaging for assessment of renal function, complications, and stone clearance.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

90

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Egipt
      • Tanta, Egipt
        • Rekrutacyjny
        • Department of Urology- Tanta University Hospitals
        • Kontakt:
        • Główny śledczy:
          • I Elmaadawy, MD
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egipt
        • Rekrutacyjny
        • Department of Urology- Beni-Suef University Hospitals
        • Kontakt:
        • Główny śledczy:
          • Hany F Badawy, MD
    • Minya Governorate
      • Minya, Minya Governorate, Egipt
        • Rekrutacyjny
        • Department of Urology- Minia University Hospitals
        • Kontakt:
          • M Abdelmalek, MD
          • Numer telefonu: +20 11 00464753
        • Główny śledczy:
          • M Abdelmalek, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Calculous anuria secondary to a single upper ureteral stone.
  • Solitary functioning kidney, whether anatomical or functional.
  • Single upper ureteral stone confirmed by non-contrast computed tomography.
  • Stone size from 6 mm to 20 mm in maximum diameter.
  • Patient considered suitable for either initial JJ ureteral stent drainage or percutaneous nephrostomy drainage.
  • Candidate for definitive treatment by flexible ureteroscopy/retrograde intrarenal surgery.
  • Documented renal functional improvement and clinical stabilization before definitive RIRS.
  • Negative or appropriately treated urine culture before definitive RIRS.
  • Ability and willingness to provide written informed consent.

Exclusion Criteria:

  • Multiple stones or bilateral stones not fitting the solitary-kidney study design.
  • Renal pelvic, distal ureteral, or multiple ipsilateral stones.
  • Stone burden greater than 20 mm.
  • Septic shock, hemodynamic instability, or need for emergency dialysis at presentation.
  • Pyonephrosis requiring a non-randomized drainage decision.
  • Anatomical abnormalities affecting endoscopic access, such as horseshoe kidney, pelvic kidney, ureterocele, or ureteral stricture.
  • Previous ipsilateral ureteral reconstructive surgery.
  • Uncorrected coagulopathy.
  • Pregnancy.
  • Genitourinary malignancy.
  • Inability to complete follow-up.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: JJ Ureteral Stent Drainage Group
Participants randomized to this arm will undergo emergency retrograde placement of a 6 Fr double-J ureteral stent under cystoscopic guidance for decompression of calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, definitive flexible ureteroscopy/retrograde intrarenal surgery will be performed according to the standardized study protocol.
Procedura: Initial JJ Ureteral Stent Drainage
Retrograde cystoscopic placement of a 6 Fr JJ ureteral stent for initial upper urinary tract decompression in patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.
Aktywny komparator: Percutaneous Nephrostomy Drainage Group
Participants randomized to this arm will undergo emergency ultrasound-guided placement of an 8 Fr percutaneous nephrostomy tube for decompression of calculous anuria caused by a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, definitive flexible ureteroscopy/retrograde intrarenal surgery will be performed according to the standardized study protocol.
Procedura: Initial Percutaneous Nephrostomy Drainage
Ultrasound-guided placement of an 8 Fr percutaneous nephrostomy tube for initial upper urinary tract decompression in patients presenting with calculous anuria due to a single upper ureteral stone in a solitary functioning kidney. After renal functional improvement, clinical stabilization, and appropriate urine culture management, participants will undergo standardized definitive flexible ureteroscopy/retrograde intrarenal surgery.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Serum Creatinine From After Initial Drainage to After Definitive RIRS
Ramy czasowe: From 24-48 hours after initial drainage to postoperative day 1 after definitive RIRS
Serum creatinine will be measured in mg/dL at 24-48 hours after initial drainage and on postoperative day 1 after definitive tratment of stone by retrograde intrarenal surgery. The primary outcome will compare the change in serum creatinine from the post-drainage value to the post-RIRS value between the JJ ureteral stent drainage group.
From 24-48 hours after initial drainage to postoperative day 1 after definitive RIRS

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
First-Session Definitive RIRS Success Rate
Ramy czasowe: During the definitive RIRS procedure
First-session definitive RIRS success will be defined as successful completion of flexible ureteroscopy/retrograde intrarenal surgery for the target upper ureteral stone in the planned first definitive session without the need to abort the procedure or schedule an additional unplanned definitive stone procedure during the same treatment pathway. The proportion of participants achieving first-session success will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group.
During the definitive RIRS procedure
Stone-Free Rate After Definitive RIRS
Ramy czasowe: 4 weeks after definitive RIRS
Stone-free rate will be defined as the proportion of participants with no detectable residual target stone fragment on follow-up non-contrast computed tomography performed 4 weeks after definitive flexible ureteroscopy/retrograde intrarenal surgery. Stone-free rate will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group
4 weeks after definitive RIRS
During the definitive RIRS procedure
Ramy czasowe: During the definitive RIRS procedure
Total operative time will be measured in minutes from insertion of the cystoscope or ureteroscope to completion of the definitive flexible ureteroscopy/retrograde intrarenal surgery procedure. Mean or median operative time will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group.
During the definitive RIRS procedure
Need for Ureteral Stenting After Definitive RIRS
Ramy czasowe: At the end of the definitive RIRS procedure
The need for postoperative ureteral stent placement after definitive flexible ureteroscopy/retrograde intrarenal surgery will be recorded. The proportion of participants requiring postoperative stenting will be compared between both drainage groups
At the end of the definitive RIRS procedure
Intraoperative Complications During Definitive RIRS
Ramy czasowe: During the definitive RIRS procedure
Intraoperative complications will include ureteral mucosal injury, false passage, ureteral perforation, bleeding affecting visualization, and procedure interruption. The incidence of intraoperative complications will be compared between both drainage groups.
During the definitive RIRS procedure
Postoperative Infectious Complications After Definitive RIRS
Ramy czasowe: From definitive RIRS to 4 weeks after definitive RIRS
Postoperative infectious complications will include fever greater than 38°C, systemic inflammatory response syndrome, or sepsis after definitive flexible ureteroscopy/retrograde intrarenal surgery. The incidence of postoperative infectious complications will be compared between both drainage groups.
From definitive RIRS to 4 weeks after definitive RIRS

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Ureteral Access Sheath Insertion Success Rate
Ramy czasowe: During the definitive RIRS procedure
Ureteral access sheath insertion success will be defined as successful placement of a ureteral access sheath during definitive flexible ureteroscopy/retrograde intrarenal surgery without the need for active ureteral dilatation, semirigid ureteroscopy assistance, or abandonment of sheath placement. The proportion of successful ureteral access sheath insertion will be compared between the JJ ureteral stent drainage group and the percutaneous nephrostomy drainage group.
During the definitive RIRS procedure

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Beni-Suef University

Śledczy

  • Główny śledczy: Hany F Badawy, MD, Faculty of medicine BeniSuef University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

6 maja 2026

Zakończenie podstawowe (Szacowany)

1 marca 2027

Ukończenie studiów (Szacowany)

1 kwietnia 2027

Daty rejestracji na studia

Pierwszy przesłany

30 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 maja 2026

Pierwszy wysłany (Rzeczywisty)

4 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • FMB050526-ANURIA-RIRS

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be shared because the study includes individual-level clinical, laboratory, radiological, operative, and microbiological data from patients presenting with an emergency urological condition. Only aggregated and de-identified study results will be reported. Any future sharing of individual participant data would require additional approval from the Research Ethics Committee and an appropriate data-sharing agreement.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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